To view detailed information about the following categories of clinical trials, click on one of the three boxes below.

  • LDL-C Goal Attainment and LDL-C Reductions

    See how CRESTOR compares to other statins in lowering LDL cholesterol. Review LDL-C goal attainment and LDL-C reductions results from comparative clinical trials in which CRESTOR was used as an adjunct to diet in patients who started statin therapy.

    Learn about LDL-C reduction results

  • Slowing Atherosclerosis Progression

    Review results from the METEOR trial, demonstrating the effects of CRESTOR treatment as an adjunct to diet on the progression of atherosclerosis.

    Learn more about atherosclerosis progression

  • Additional Clinical Data

    Explore additional clinical trial data reviewing the use of CRESTOR in LDL-C reductions for patients switching therapy, CVD prevention, raising HDL-C, and efficacy in other increased-risk patient populations.

    Learn about additional trial data

Next: ECLIPSE and STELLAR Trials

Important Safety Information for CRESTOR® (rosuvastatin) Tablets

  • CRESTOR is contraindicated in patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels or a known hypersensitivity to any component of this product
  • Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with statins, including CRESTOR. These risks can occur at any dose level, but are increased at the highest dose (40 mg)
  • CRESTOR should be prescribed with caution in patients with predisposing factors for myopathy (eg, age ≥65 years, inadequately treated hypothyroidism, renal impairment). The risk of myopathy during treatment with CRESTOR may be increased in Asian patients and with concurrent administration of some other lipid-lowering therapies (fibrates or niacin), cyclosporine, teriflunomide, enasidenib, capmatinib, fostamatinib, febuxostat, gemfibrozil, tafamidis, darolutamide, regorafenib, atazanavir/ritonavir, lopinavir/ritonavir, simeprevir or combination of sofosbuvir/velpatasvir/voxilaprevir, dasabuvir/ombitasvir/paritaprevir/ritonavir, elbasvir/grazoprevir, sofosbuvir/velpatasvir, glecaprevir/pibrentasvir, all combinations with ledipasvir (including ledipasvir/sofosbuvir), colchicine or ticagrelor
  • Therapy with CRESTOR should be discontinued if markedly elevated CK levels occur or myopathy is diagnosed or suspected. All patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever, and if muscle signs and symptoms persist after discontinuing CRESTOR
  • There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use. IMNM is characterized by proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with immunosuppressive agents. Treatment with immunosuppressive agents may be required. Discontinue CRESTOR if IMNM is suspected
  • Increases in serum transaminases have occurred, some persistent. Rare reports of fatal and non-fatal hepatic failure have occurred. Consider testing liver enzymes before initiating therapy and as clinically indicated thereafter. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue CRESTOR
  • CRESTOR should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of chronic liver disease
  • CRESTOR significantly increased INR in patients receiving coumarin anticoagulants (eg, warfarin). In patients taking coumarin anticoagulants and CRESTOR concomitantly, INR should be determined before starting CRESTOR and frequently enough during early therapy to ensure that no significant alteration of INR occurs
  • Dipstick-positive proteinuria and microscopic hematuria were observed among patients treated with CRESTOR. These findings were more frequent in patients taking CRESTOR 40 mg, though it was generally transient and was not associated with worsening renal function. Although the clinical significance of this finding is unknown, dose reduction should be considered for patients on CRESTOR therapy with unexplained persistent proteinuria and/or hematuria during routine urinalysis testing
  • Increases in HbA1c and fasting serum glucose levels have been reported with statins, including CRESTOR. Based on clinical trial data with CRESTOR, in some instances these increases may exceed the threshold for the diagnosis of diabetes mellitus
  • In the controlled clinical trials database, the most common adverse reactions were headache (3.7%), myalgia (3.1%), abdominal pain (2.6%), asthenia (2.5%), and nausea (2.2%)
  • Rare post-marketing reports of cognitive impairment (eg, memory loss, forgetfulness, amnesia, memory impairment, confusion) have been associated with statin use, including CRESTOR. These reports are generally nonserious and reversible upon statin discontinuation
  • Discontinue CRESTOR when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient
  • CRESTOR 40 mg should be used only for those patients not achieving their LDL-C goal with 20 mg
  • Administer CRESTOR at least 2 hours before aluminum and magnesium hydroxide combination antacids

INDICATIONS

  • To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor
  • Adjunct to diet to:
    • reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia
    • reduce LDL-C and slow the progression of atherosclerosis in adults
    • reduce LDL-C in patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH)
  • Adjunct to other LDL-C lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH)
  • Adjunct to diet for the treatment of adults with primary dysbetalipoproteinemia or hypertriglyceridemia

Read full Prescribing Information.

You may report side effects related to AstraZeneca products.

References:

1a 1b 1c 1d 1e 1f 1g 1h 1i CRESTOR® (rosuvastatin) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024.

  • 1a 1b 1c 1c 1d CRESTOR® (rosuvastatin) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024.
  • ^ Falk, E; Aarhus University Hospital (Skejby). Pathogenesis of atherosclerosis. Am J Cardiol. 2006;47(8):C7-12.
  • ^ Nissen, S; Cleveland Clinic Foundation. Rationale for a postintervention continuum of care; insights from intravascular ultrasound. Am J Cardiol. 2000;86(4):H12-17.
  • ^ Lexcol® (fluvastatin sodium) [package insert]. East Hanover, New Jersey: Novartis; 2020
  • ^ Mevacor® (lovastatin) [package insert]. Whitehouse Station, New Jersey: Merck & Company, Inc. 2012
  • ^ Pravachol® (pravastatin) [package insert]. Princeton, New Jersey: Bristol-Myers Squibb Company, 2020.
  • ^ Lipitor® (atorvastatin) [package insert]. New York, New York: Pfizer, 2021
  • ^ Livalo® (pitavastatin) [package insert]. Montgomery, AL: Kowa group of companies, 2020.
  • ^ Zocor® (simvastatin) [package insert]. Jersey City, NJ: Organon & Company, 2022
  • ^ Vytorin® (ezetimibe/simvastatin) [package insert]. Jersey City, NJ: Organon & Company, 2022.
  • ^ Lexcol® (fluvastatin sodium) [package insert]. East Hanover, New Jersey: Novartis; 2020
  • ^ Mevacor® (lovastatin) [package insert]. Whitehouse Station, New Jersey: Merck & Company, Inc. 2012
  • ^ Pravachol® (pravastatin) [package insert]. Princeton, New Jersey: Bristol-Myers Squibb Company, 2020.
  • ^ Lipitor® (atorvastatin) [package insert]. New York, New York: Pfizer, 2021
  • ^ Livalo® (pitavastatin) [package insert]. Montgomery, AL: Kowa group of companies, 2020.
  • ^ Zocor® (simvastatin) [package insert]. Jersey City, NJ: Organon & Company, 2022
  • ^ Vytorin® (ezetimibe/simvastatin) [package insert]. Jersey City, NJ: Organon & Company, 2022.
  • ^ Faergeman O, Hill L, Windler E, et al; on behalf of the ECLIPSE Study Investigators. Efficacy and tolerability of rosuvastatin and atorvastatin when force-titrated in patients with primary hypercholesterolemia. Cardiology. 2008;111(4):219-228.
  • ^ Ballantyne CM, Bertolami M, Hernandez Garcia HR, et al. Achieving LDL cholesterol, non-HDL cholesterol, and apolipoprotein B target levels in high-risk patients: Measuring Effective Reductions in Cholesterol Using Rosuvastatin therapY (MERCURY) II. Am Heart J. 2006;151(5):975.e1-975.e9.
  • ^ Schuster H, Barter PJ, Stender S, et al. Effects of switching statins on achievement of lipid goals: Measuring Effective Reductions in Cholesterol Using Rosuvastatin therapY (MERCURY I) study. Am Heart J. 2004;147(4):705-713.
  • ^ Jones PH, Davidson MH, Stein EA, et al; STELLAR Study Group. Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR Trial). Am J Cardiol. 2003;92(2):152-160.
  • ^ CRESTOR® (rosuvastatin) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024.
  • ^ Betteridge DJ, Gibson JM; ANDROMEDA Study Investigators. Effects of rosuvastatin on lipids, lipoproteins, and apolipoproteins in the dyslipidaemia of diabetes. Diabet Med. 2007;24(5):541-549.
  • ^ Berne C, Siewert-Delle A; URANUS Study Investigators. Comparison of rosuvastatin and atorvastatin for lipid lowering in patients with type 2 diabetes mellitus: results from the URANUS study. Cardiovasc Diabetol. 2005;4:7.
  • ^ Ferdinand KC, Clark LT, Watson KE, et al; ARIES Study Group. Comparison of efficacy and safety of rosuvastatin versus atorvastatin in African-American patients in a six-week trial. Am J Cardiol. 2006;97(2):229-235.
  • ^ Lloret R, Yčas J, Stein M, Haffner S; STARSHIP Study Group. Comparison of rosuvastatin versus atorvastatin in Hispanic-Americans with hypercholesterolemia (from the STARSHIP trial). Am J Cardiol. 2006;98(6):768-773.
  • ^ Data on File, REF-148952, AstraZeneca Pharmaceuticals LP.
  • 11a 11b Data on File, REF-148935, AstraZeneca Pharmaceuticals LP.
  • ^ Guyton AC, Hall JE. Textbook of Medical Physiology. 11th ed. Philadelphia, PA: Elsevier Inc; 2006.
  • ^ Lusis AJ. Atherosclerosis. Nature. 2000;407:233-241.
  • ^ National Heart, Lung, and Blood Institute. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III): Final Report. Bethesda, MD: National Institutes of Health; 2002. NIH Publication 02-5215
  • 1a 1b CRESTOR® (rosuvastatin) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024.
  • ^ Lusis AJ. Atherosclerosis. Nature. 2000;407:233-241.
  • ^ Naghavi M, Falk E, Hecht HS, et al; for the SHAPE Task Force. From vulnerable plaque to vulnerable patient—part III: executive summary of the Screening for Heart Attack Prevention and Education (SHAPE) Task Force report. Am J Cardiol. 2006;98(suppl):2H-15H.
  • ^ Falk E. Pathogenesis of atherosclerosis. J Am Coll Cardiol. 2006;47(suppl):C7-C12.
  • ^ Crouse JR 3rd, Raichlen JS, Riley WA, et al; METEOR Study Group. Effect of rosuvastatin on progression of carotid intima-media thickness in low-risk individuals with subclinical atherosclerosis: the METEOR Trial. JAMA. 2007;297(12):1344-1353.
  • ^ Data on File, REF-148945, AstraZeneca Pharmaceuticals LP.
  • 1a 1b 1c CRESTOR® (rosuvastatin) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024.
  • ^ Faergeman O, Hill L, Windler E, et al; ECLIPSE Study Investigators. Efficacy and tolerability of rosuvastatin and atorvastatin when force-titrated in patients with primary hypercholesterolemia: results from the ECLIPSE study. Cardiology. 2008;111(4):219-228.
  • 3a 3b Faergeman O, Sosef F, Duffield E; on behalf of the ECLIPSE study investigators. Efficacy and tolerability of rosuvastatin and atorvastatin when force titrated in high-risk patients: results from the ECLIPSE study. Poster presented at: 14th International Symposium on Atherosclerosis; June 18-22, 2006; Rome, Italy.
  • Grundy SM, Cleeman JI, Merz CNB, et al; for the Coordinating Committee of the National Cholesterol Education Program. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation. 2004;110:227-239.
  • ^ Jones PH, Davidson MH, Stein EA, et al; for the STELLAR Study Group. Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR Trial). Am J Cardiol. 2003;92:152-160.
  • 6a 6b 6c McKenney JM, Jones PH, Adamczyk MA, Cain VA, Bryzinski BS, Blasetto JW; STELLAR Study Group. Comparison of the efficacy of rosuvastatin versus atorvastatin, simvastatin, and pravastatin in achieving lipid goals: results from the STELLAR trial. Curr Med Res Opin. 2003;19(8):689-698.
  • ^ Data on File, REF-148955, AstraZeneca Pharmaceuticals LP
  • ^ Nicholls SJ, Brandrup-Wognsen G, Palmer N, et al. Meta-analysis of comparative efficacy of increasing dose of atorvastatin versus rosuvastatin versus simvastatin on lowering levels of atherogenic lipids (from VOYAGER). Am J Cardiol. 2010;105:69-76.

1a 1b 1c 1d 1e 1f 1g 1h 1i 1j 1k 1l 1m 1n 1o 1p 1q 1r CRESTOR® (rosuvastatin) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024.

1a 1b 1c 1d1d CRESTOR® (rosuvastatin) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024.

  • 1a CRESTOR® (rosuvastatin) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024.
  • 2a Lipitor® (atorvastatin calcium) [prescribing information]. Morgantown, WV: Viatris Specialty LLC, 2024.
  • 3a Faergeman O, Hill L, Windler E, et al; on behalf of the ECLIPSE Study Investigators. Efficacy and tolerability of rosuvastatin and atorvastatin when force-titrated in patients with primary hypercholesterolemia. Cardiology. 2008;111(4):219-228.
  • 4a Jones PH, Davidson MH, Stein EA, et al; for the STELLAR Study Group. Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR Trial). Am J Cardiol. 2003;92:152-160.
  • 5a Crouse JR 3rd, Raichlen JS, Riley WA, et al; METEOR Study Group. Effect of rosuvastatin on progression of carotid intima-media thickness in low-risk individuals with subclinical atherosclerosis: the METEOR Trial. JAMA. 2007;297(12):1344-1353.

Lipitor is a registered trademark of Upjohn Manufacturing Ireland Unlimited Company, a Viatris Company.

1a 1b 1c 1d CRESTOR® (rosuvastatin) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024.

This product information is intended for US Health Care Professionals only.

IMPORTANT SAFETY INFORMATION FOR CRESTOR® (ROSUVASTATIN) TABLETS

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